Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01 Clinical Trial Not Allowed)

Funding Opportunity Description Background The NIAID Division of AIDS (DAIDS) maintains resources for preclinical gap-filling support to develop promising HIV therapeutics and to enable filing an Investigational New Drug (IND) application with the Food and Drug Administration. The Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program provides a standard way for investigators to request gap-filling services and is intended to reduce barriers in the drug development process This announcement supports the National Institute of Allergy and Infectious Diseases (NIAID) mission to conduct and support basic and applied research to treat infectious diseases with a focus on: (1) Development of Next-Generation HIV Therapies (drugs with improved safety and ease of use, e.g., sustained release antiretrovirals; novel HIV targets & inhibitors; novel immune-based therapies) and (2) Addressing HIV-associated comorbidities, coinfections, and complications. Purpose and Scope The purpose of the RAPIDD Program is to provide investigators working in the area of drug development for treatment of HIV and HIV-associated co-infections, hepatitis B virus (HBV), hepatitis C virus (HCV), and Tuberculosis (TB) access to DAIDS preclinical services for specific tasks. Applicants are not required to have current NIH funding to apply. It is expected that resources other than those supported by the RAPIDD Program will be sought or in place to complete the drug development program. Requested services may not overlap with efforts already funded through the Department of Health and Human Services. Projects in both the early and late stages of preclinical development are suitable for this announcement. Experimental therapeutics may include small organic molecules, polymers, or biologics (e.g., peptides, oligonucleotides, antibodies), cellular and genetic drug products (e.g., CAR-T cells). Available services include, but are not limited to: A) In Vitro Testing and Screening of HIV Compounds High through-put screening of compound libraries in cell-based or biochemical assays Testing in human peripheral blood mononuclear cells (PBMCs) and/or continuous cell lines to confirm the activity of anti-HIV therapeutic agents Hit-to-Lead progression studies to optimize lead anti-HIV therapeutic candidates and analogs HIV drug resistance testing B) Evaluations in Small Animal Models for HIV, HBV, HCV and MTB Supported studies include pharmacokinetic (PK), safety, and efficacy studies to characterize products, inform dose selection, optimize formulations, and/or obtain other information necessary to advance or support product testing in subsequent large animal or human studies (supported under different mechanisms). Xenograft models will utilize postnatal human cells and tissue. Studies of Mycobaterium are limited to Mycobacterium tuberculosis and do not include other Mycobacterium species. Assessment of mainly therapeutics, but also vaccines, other prophylactic methods, and diagnostics for use against HIV, HBV, HCV and MTB in small animal models Clinical manifestations, body weight, complete blood counts, and serum chemistries to determine the health of the animals during the study Assays and assay components to support animal model improvement and in vivo product evaluation When applicable, other activities (e.g., immunology, histopathology, in situ hybridization, whole body and tissue imaging, etc.) may be supported as well C) Formulation Development and Manufacture of Clinical Dosage Forms for HIV and HIV-associated Co-infections HBV, HCV, and TB Development of alternative dosage forms (strength, physical form, route of administration) Development of new formulations to improve drug properties Development and validations of analytical assays to determine the identity, strength, quality, and purity of drug products, and stability indicating assays Drug product manufacturing in compliance with Current Good Manufacturing Practice (cGMP) Stability studies D) Preclinical Pharmacology and Toxicology for HIV and HIV-associated Coinfections HBV, HCV, and TB Pharmacology studies in animal species Good Laboratory Practice (GLP) compliant toxicology and safety pharmacology studies Genotoxicity and off-target toxicity evaluations of drug candidates In vitro Absorption, Distribution, Metabolism, Elimination, Toxicity (ADMET) studies of lead compounds Development of new toxicology models and test systems, such as 3-dimensional culture, hollow-fiber cell culture, or organ-on-a-chip technology. Services requested are expected to be narrowly focused to fill gaps in areas of need identified by the applicant. Interested parties are strongly encouraged to reach out to the Scientific/Research Contact to discuss potential service requests prior to application submission. Typically, services for A, C, and D will not exceed 12 months. Requests for B, "Evaluations in Small Animal Models for HIV, Hepatitis B, Hepatitis C and TB" may extend to 24 months. Applicants may request services for multiple areas (e.g., any service within A, B, C, or D above); however, each service requires a separate application submission with a strong justification. Intellectual Property It is expected that the originating investigator, institution or a collaborating partner will have acquired or be in the process of acquiring appropriate intellectual property protection prior to application to the RAPIDD Program. Resource services will be provided through existing DAIDS preclinical contracts. While it is unlikely the NIH staff will make an inventive contribution to any intellectual property developed under the RAPIDD Program, in accordance with 37 CFR Part 501, the government has rights to any invention made by federal employees and its employees have a duty to report all inventions. If the NIH does file a patent application claiming one or more inventions developed under the RAPIDD Program, the originating investigator institution will be given the opportunity to negotiate for an exclusive license under procedures set forth in 37 CFR Part 404. NIH contractors, under the Bayh-Dole Act, may elect to retain rights for a contribution they make that rises to the level of invention. However, some contractors, as a term of their funding agreements, have agreed to offer a first option to the originating investigator institution for license negotiation. If the applicant is selected for resource support, a Material Evaluation Agreement or other agreement may be required prior to initiation of work, which will define how intellectual property is managed under the specific contract(s) under which such support would be provided. Questions or concerns about Intellectual Property should be discussed with NIAID staff prior to application. See Section VIII. Other Information for award authorities and regulations.